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A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Relapsed or Therapy Refractory Ewing Sarcoma (ASCT)

This study has been withdrawn prior to enrollment.
(No subjects meeting study inclusion were enrolled.)
Information provided by (Responsible Party):
University of Louisville Identifier:
First received: October 21, 2013
Last updated: May 8, 2017
Last verified: May 2017

The purpose of this study is to examine the toxicity of using allogeneic stem cell transplantation for treatment of subjects with relapsed or refractory Ewing Sarcoma (ES). Donors will consist of either Human Leukocyte Antigen identical (HLA)or 9/10 (A, B, C, DR, DQ [A, B, C, are Class I markers for HLA and DR and DQ are Class II markers for Matching for Transplant for Donors to match with recipient]) matched related or unrelated donors. Specifically, we will examine:

  • The toxicity of allogeneic stem cell transplant (SCT) in this patient population, as related to incidence of grade 3-4 acute Graft Verse Host Disease (GVHD).
  • The incidence of transplant related mortality at 100 days.

Condition Intervention Phase
Ewing Sarcoma
Biological: allogeneic stem cell transplantation
Drug: Clyclophosphamide
Drug: Fludarabina
Drug: Busulfan
Drug: Melphalan
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Relapsed or Therapy Refractory Ewing Sarcoma

Resource links provided by NLM:

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Development of Grade 3-4 GVHD [ Time Frame: 12 months ]

Enrollment: 0
Study Start Date: April 2013
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: allogeneic stem cell transplantation Plan A
Subjects will receive the vaccine, Busulfan and Melphalan.
Biological: allogeneic stem cell transplantation Drug: Busulfan Drug: Melphalan
Experimental: allogeneic stem cell transplantation Plan B
If subject have already received a stem cell transplant using Busulfan and Melphalan, they will receive Clysophosohamide and Fludarabine.
Biological: allogeneic stem cell transplantation Drug: Clyclophosphamide Drug: Fludarabina


Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients aged 0-30 years with relapsed or therapy refractory Ewings sarcoma, excluding patients with brain metastases. Patients who have received a prior autologous stem cell transplant are eligible.
  • Related and unrelated marrow and peripheral blood stem donors must be 9/10 or 10/10 (HLA A, B, C, DR, DQ) matched with the recipient.

Exclusion Criteria:

  • Organ dysfunction: Patients who have the following levels of organ system dysfunction are not eligible:

    • Cardiac: Ejection Fraction less than 50 percent
    • Renal: Est. Creatinine Clearance less than 50
    • Hepatic: Bilirubin greater than 3.0
    • Pulmonary: Diffusing Capacity for Carbon Monoxide (DLCO) less than 70 percent, or for patient who cannot cooperate with pulmonary function testing, O2 saturation less than 95 percent on room air.
  • Performance status: Lansky performance less than 70; Eastern Cooperative Oncology Group (ECOG) status greater than or equal to 2
  • Patients with an isolated recurrence of their tumor (in the site of primary tumor) greater than 1 year after completing therapy are excluded as these patients could be cured with local therapy alone.

    • As part of the standard of care for pre-transplant evaluation subjects will be tested for exposure to viral agents such as hepatitis B, C, HTLV-1/2 and HIV. Subjects testing positive for HI may be rejected as candidates for transplantation, based on the clinical judgement of the stem cell transplant physician.
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Please refer to this study by its identifier: NCT01969942

United States, Kentucky
Pediatric Hematology/Oncology University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Principal Investigator: Kenneth Lucas, M.D. University of Louisville
  More Information

Additional Information:
Responsible Party: University of Louisville Identifier: NCT01969942     History of Changes
Other Study ID Numbers: 13.0176
Study First Received: October 21, 2013
Last Updated: May 8, 2017

Keywords provided by University of Louisville:
Ewings sarcoma

Additional relevant MeSH terms:
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Antineoplastic Agents
Myeloablative Agonists processed this record on May 24, 2017